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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

FDA Accepts for Review First NDA for a 'Digital' Medicine

The US Food and Drug Administration (FDA) has accepted for review what is being considered the first new drug application (NDA) for a combination product to include a sensor embedded into the tablet.

The developer of the sensor – Proteus Digital Health – said it could help improve patient medication adherence and better inform physician decision-making to tailor treatments to the patient's needs.

In the case of this new drug application, the sensor is paired with Otsuka Pharmaceutical's FDA-approved Abilify (aripiprazole). The combo product includes the tablet, which contains an ingestible sensor that communicates with a wearable sensor patch and a medical software application for measuring adherence in the treatment of adults with schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, and as adjunctive therapy for the treatment of major depressive disorder in adults.

When ingested, the sensor sends a signal to the wearable patch after it reaches the stomach. The patch then records and time-stamps the information from the ingestible sensor in addition to collecting other metrics, including rest, body angle and activity patterns. This information is recorded and relayed to patients on a mobile phone or other Bluetooth-enabled device, and with their consent, to a physician or other caregiver.

Patients can view the information via the software application on their mobile phone or device while physicians or caregivers can view the data using secure web portals.

The companies say this is the first time an FDA-approved medication has been combined and submitted for approval with a sensor within the tablet to measure medication-taking patterns and physiologic response.

Dr. William Carson, president and CEO of Otsuka, said in a statement: "We believe this new digital medicine could revolutionize the way adherence is measured and fulfill a serious unmet medical need in this population. We look forward to continuing working with the FDA throughout the NDA review."